close
"Top 60 Chinese Biofirms Propel Industry Forward"
Source: Genetic Engineering & Biotechnology News Vloume 28 Number 4 February 15, 2008
Author: Eliza Yibing Zhou
Key Points:
1. Shenzhen Kexing Biotech is the first modern biotech firm inaugurated in China. The first Chinese-developed protein therapeutic (recombinant human interferon alpha-1b was brought to the market by Kexing in the early 1990s.
2. Nearly 200 modern biotech drug firms have followed, and they have launched 35 biotech drugs to the domestic market in recent years.
3. A newly released study "Top 60 Chinese-Owned Biopharmaceutical Companies" is published by BioPlan Associates (www.bioplanassociates.com), and this is believed to be the first in-depth study of Chinese biotech firms.
4. While the majority of the Chinese biotechs are dedicated to the development and commercialization of the follow-on biologics, several Chinese biotech innovators have launched biotech therapeutics amied at the global markets.
5. In 2004, Shenzhen Sibiono GeneTech, for example, reportedly commercialized the world's first gene therapy product, recombinant human adenovirus-p53 injection under the brand name of Gendicine. (The company reports that Gendicine has shown to be beneficial in the treatment of over 40 kinds of solid tumors).
6. In November 2005, China's State Food and Drug Administration (SFDA) approved Shanghai Sunway Biotech's recombinant human adenovirus type 5 injection (Oncorine or H101) in combination with chemotherapy for the treatment of patients with late-stage refractory nasopharyngeal cancer. (This is the world's first oncolytic viral therapy approved by a regulatory agency.
7. In 2006, Shandong Simcere Medgenn Biopharmaceutical launched another world's first, a commercial recombinant human endostatin (Endu) for treatment of non-small-cell lung cancer.
8. In China, the biopharmaceutical industry has been recognized by the government as the most important and promising sector for the 21st century. With a healthy 20-25% annual growth rate and a diversified pipeline, the Chinese biopharmaceutical industry is moving toward globalization.
9. Big Chinese CMOs are launching biopharma businesses by teaming up with international biotech giants such as the partnership between Zhejiang Hisun Pharma and Amgen.
10. The first Chinese biotech companies were mostly vaccine providers. The earliest traditional vaccine producer, National Serum and Vaccine Institute (NVSI) was founded in 1919. NVSI is recently one of the 9 subsidiaries directly controlled by China National Biotech Group (CNBG). It has more than 9,000 employees and worldwide revenues of $421 million in 2006. To date, CNBG has marketed 34 vaccines (mostly traditional vaccines), 17 hematologic products, and over 30 diagnostic agent, primarily in the domestic market.
11. Two CNBG subsidiaries are preparing to obtain WHO prequalification for a Japanese encephalitis vaccine and polyvalent rotavirus vaccine through collaborations with PATH.
12. Meanwhile, NVSI in partnership with Beijing Tiantan Biological Products and the Virology Institute at China Disease Control Center is working on establishing a National Engineering Center for Novel Vaccines.
13. According to the SFDA, Chinese vaccine producers have marketed 49 vaccines to fight 26 infectious diseases with an annual output of over one billion doses. As a result of the work of these traditional biotech companies, China aims to be the world's largest vaccine manufacturing country in terms of production scale.
14. Foreign Biotech Competition: The most successful foreign biotech player in the Chinese market today is Novo Nordisk, which entered the Chinese market in 1993 and opened its first production facility in Tianjin in 1996. Novo Nordisk has grown rapidly in China and has dominated the human insulin market there for many years, with 1.9 billion RMB ($261 million) sales in 2006.
15. Another aggressive foreign player is Sanofipasteur, which set up an influenza vaccine facility in Shenzhen in 1996. In November 2007, the company announced that it would invest 700 million RMB (94 million) to expand facilities in Shenzhen, with the goal of producing seasonal influenza vaccines for the Chinese market by 2012.
16. GlaxoSmithKline also set up an influenza vaccine production facility in Shanghai Zhangjiang High-Tech Park in 2004.
17. Threats and Weaknesses:
Treats:
1. China's entry to the WTO in 2001. With the largest population, if China fails to develop its own proprietary products, the country will become the world's biggest destination for imported products.
2. Some Chinese biosimilar manufacturers with limited knowledge of international IP law may be faced with potential IP conflicts or lawsuits from foreign companies.
3. Higher tax rates, the increase of raw material costs, potential government-imposed drug price cuts, and the lack of a strong, mature capital market and the use of government investments to fund biotech research.
Weaknesses:
1. Size: Chinese biotech firms remain small.
2. R&D: The majority of Chinese biotechs do not invest enough in R&D and as a result do not possess innovative research personnel.
3. Production: So far, no Chinese biopharma has managed to obtain Western GMP certifications or WHO prequalification.
4. Management and Marketing: Many companies do not have managers with international managerial or marketing experience.
Chinese biotech firms still remain diamonds-in-the-rough. It is only a matter of time before these biotech firms become influential players in the global market. We will not be surprised if 10 years from now, some Chinese companies in our directory of the top 60 biofirms will have become well-known names in the international biotech community.
全站熱搜
留言列表
